Pain
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Randomized Controlled Trial
The relationship of sociodemographic and psychological variables to chronic pain variables in a low-income population.
Chronic pain is a pervasive condition that is complicated by economic, educational, and racial disparities. This study analyzes key factors associated with chronic pain within an understudied and underserved population. The sample is characterized by a triple disparity with respect to income, education/literacy, and racial barriers that substantially increase the vulnerability to the negative consequences of chronic pain. ⋯ Depressive symptoms and pain catastrophizing mediated the relationships between age and pain variables, whereas pain catastrophizing mediated the effects of primary literacy and poverty status. Some reversed models were equivalent to the hypothesized models, suggesting the possibility of bidirectionality. Although cross-sectional findings cannot establish causality, our results highlight the critical role psychological factors play in individuals with chronic pain and multiple health disparities.
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Randomized Controlled Trial
The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme.
The Stanford Chronic Pain Self-Management Programme (CPSMP) consists of 6 2½-hour weekly workshops focusing on how to manage pain in daily life. The workshops are facilitated by 2 workshop leaders of whom at least 1 must suffer from a long-term pain condition. The program is highly structured and manualized. ⋯ Small positive effects on emotional distress and illness worry 3 months after CPSMP were observed. Lay-led CPSMP is not recommended as treatment for chronic pain-related disability. This heterogeneous group of patients with pain did not benefit from the CPSMP except for a small, but clinically insignificant improvement in psychological well-being.
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Randomized Controlled Trial
Midazolam as an active placebo in three fentanyl-validated nociceptive pain models.
The use of inactive placebos in early translational trials of potentially analgesic compounds is discouraged because of the side-effect profiles of centrally acting analgesics. Therefore, benzodiazepines are used, although their use has not been validated in this context. Whether benzodiazepines confound the results of acute pain tests is unknown. ⋯ The findings of this study show that midazolam can be used as an active placebo in analgesic drug trials. Furthermore, the proposed models were simple to implement and very effective in detecting analgesia. The test battery can be used in translational trials for new compounds and comes with an active placebo and an optional active comparator.
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Randomized Controlled Trial
Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial.
In randomized controlled trials, medication side effects may lead to beliefs that one is receiving the active intervention and enhance active treatment responses, thereby increasing drug-placebo differences. We tested these hypotheses with an experimental double-blind randomized controlled trial of a nonsteroidal anti-inflammatory drug with and without the addition of atropine to induce side effects. One hundred healthy volunteers were told they would be randomized to either combined analgesics that might produce dry mouth or inert placebos. ⋯ A chain of mediation analysis demonstrated that the addition of atropine increased dry mouth symptoms, which increased beliefs that one had received the active medication, which, in turn, increased analgesia. In addition to this indirect effect of atropine on analgesia (via dry mouth and beliefs), analyses suggest that among those who received diclofenac, atropine directly increased analgesia. This possible synergistic effect between diclofenac and atropine might warrant future research.
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Randomized Controlled Trial Multicenter Study
A tailored guided internet-based cognitive-behavioral intervention for patients with rheumatoid arthritis as an adjunct to standard rheumatological care: Results of a randomized controlled trial.
For patients with chronic pain conditions such as rheumatoid arthritis (RA), who experience elevated levels of distress, tailored-guided internet-based cognitive-behavioral treatment may be effective in improving psychological and physical functioning, and reducing the impact of RA on daily life. A multicenter, randomized controlled trial was conducted for RA patients with elevated levels of distress as assessed by a disease-specific measure. The control group (n = 71) received standard care and the intervention group (n = 62) additionally received an internet-based tailored cognitive-behavioral intervention. ⋯ No effects were found for the impact of RA on daily life, except for the intervention group experiencing fewer role limitations due to emotional problems (P < 0.001, d = 0.53). Offering guided internet-based cognitive-behavioral therapy is a promising development to aid patients with psychological distress particularly in improving psychological functioning. Further research on adherence and specific intervention ingredients is warranted.